drug facts

drug facts
SPL v1
SPL
SPL Set ID 9aecb197-0617-4043-83e3-00e0abae5b0b
Route
topical
Published
Effective Date 2017-04-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octinoxate (7.5 mg) oxybenzone (4.0 mg) octocrylene (27.0 mg)
Inactive Ingredients
petrolatum light mineral oil .alpha.-tocopherol acetate candelilla wax menthol, (+)-

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph not final active Since 2015-08-17

Purpose

Sunscreen, Sunscreen, Sunscreen

Description

Octinoxate (7.5%), Octocrylene (2.0%), Oxybenzone (4.0%)


Medication Information

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early aging.

For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts.

Uses

Prevents Sunburns

Purpose

Sunscreen, Sunscreen, Sunscreen

Directions

Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use.

Inactive Ingredients

Petrolatum, Mineral Oil, Paraffin, Euphorbia Cerifera ( Candelilla) Wax, Theobroma Cacao (Cocoa) Seed Butter, Menthol, Propylene Glycol, Eucalyptus Globulus (Eucalyptus) Oil, Abies Sibirica Oil, Methyl Salicylate, Cinnamomum Camphora (Camphor) Bark Oil, Isopropyl Myristate, Tocopheryl Acetate, Aloe Barbadenis Leaf Extract, Paraffin, Methylparaben.

Description

Octinoxate (7.5%), Octocrylene (2.0%), Oxybenzone (4.0%)

Active Ingredient

Octinoxate (7.5%), Octocrylene (2.0%), Oxybenzone (4.0%)

Keep Out of Reach of Children

If swallowed get medical help or contact a Poison Control Center right away.

Package/label Principal Display Panel

Structured Label Content

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early aging.

For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts.

Uses

Prevents Sunburns

Purpose

Sunscreen, Sunscreen, Sunscreen

Directions

Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use.

Inactive Ingredients

Petrolatum, Mineral Oil, Paraffin, Euphorbia Cerifera ( Candelilla) Wax, Theobroma Cacao (Cocoa) Seed Butter, Menthol, Propylene Glycol, Eucalyptus Globulus (Eucalyptus) Oil, Abies Sibirica Oil, Methyl Salicylate, Cinnamomum Camphora (Camphor) Bark Oil, Isopropyl Myristate, Tocopheryl Acetate, Aloe Barbadenis Leaf Extract, Paraffin, Methylparaben.

Active Ingredient (Active ingredient)

Octinoxate (7.5%), Octocrylene (2.0%), Oxybenzone (4.0%)

Keep Out of Reach of Children

If swallowed get medical help or contact a Poison Control Center right away.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Advanced Ingredient Data


Raw Label Data

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